The goal of the Clinical Trials Support Office is to provide services that accomplish the following goals: 1) foster new research by providing assistance to investigators who are not well-established clinical researchers and need to develop staffing and skills in trials management; 2) provide quality assurance and monitoring measures for all investigators that ensure compliance with regulatory requirements; 3) improve the cost-effectiveness of research through resource optimization; 4) disseminate clinical research expertise across the Consortium. The services provided by the Clinical Trials Support Office are as follows: a) Assistance with protocol submissions; b) Coordination of protocol implementation at expected patient care locations; c) Provision of cost-effective staffing for investigators without their own dedicated staff for development and management of clinical studies; d) Provision of data and safety monitoring and oversight for all trials; e) Provision of specialized monitoring consultation for investigators with special requirements (e.g. investigators holding FDA-sponsored INDs); f) Per diem study support services.